Ignite Creation Date:
2025-12-24 @ 10:12 PM
Ignite Modification Date:
2025-12-31 @ 3:18 PM
Study NCT ID:
NCT01835535
Status:
UNKNOWN
Last Update Posted:
2014-03-26
First Post:
2013-04-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Continued Safety and Performance of the TIVUS System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C563514', 'term': 'Hypertension Resistant to Conventional Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-03-25', 'studyFirstSubmitDate': '2013-04-17', 'studyFirstSubmitQcDate': '2013-04-18', 'lastUpdatePostDateStruct': {'date': '2014-03-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-04-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in office Systolic Blood Pressure (SBP) from baseline to 6-month', 'timeFrame': '6 month'}], 'secondaryOutcomes': [{'measure': 'Procedural complications', 'timeFrame': '30 day'}, {'measure': 'Major Adverse Events (MAE)', 'timeFrame': '1 year'}, {'measure': 'Preservation of renal function', 'timeFrame': '1 year'}, {'measure': 'Cardiovascular complications', 'timeFrame': '1 year'}, {'measure': 'Blood pressure reduction', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hypertension, Resistant to Conventional Therapy']}, 'descriptionModule': {'briefSummary': 'The TIVUS II is a prospective, multicenter, non-randomized, open-label clinical study of the safety and performance of the TIVUS™ System consisting of three (3) concurrent cohorts:\n\n* TIVUS™ Severe Resistant HTN Cohort\n* TIVUS™ Moderate Resistant HTN Cohort\n* TIVUS™ Failed RF Therapy Cohort'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient is ≥ 18 and ≤ 80 years of age\n* For Cohort A: Documented office systolic blood pressure \\> 160 mmHg (\\> 150 mmHg for diabetic patients); For Cohort B: Documented office systolic blood pressure \\> 140 mmHg (\\> 130 mmHg for diabetic patients); For Cohort C: Documented office systolic blood pressure \\> 150 mmHg (\\> 140 mmHg for diabetic patients)\n* Documented 24 hour systolic ABPM \\> 135 mmHg\n* Adherence to a stable drug regimen\n* For patients in Cohort C only: Documented renal denervation procedure with any RF technology 12 months or more prior to screening\n* Suitable renal artery anatomy\n* Male or non-pregnant / non-lactating female\n* Patient understands the nature of the procedure and provides written informed consent\n* Patient is willing and able to comply with the specified study requirements and follow-up evaluations\n\nExclusion Criteria:\n\n* eGFR \\< 45mL/min/1.73m2\n* Documented primary pulmonary hypertension\n* Patient experienced \\>1 episode of orthostatic hypotension coupled with syncope\n* Documented indicator of a secondary renal hypertension\n* History of myocardial infarction, unstable angina pectoris, or a cerebrovascular accident within 6 months\n* Planned major surgery or cardiovascular intervention in the next 6 months\n* Surgery or cardiovascular intervention in the previous 3 months\n* Hemodynamically significant valvular heart disease\n* Severe debilitating lung disease\n* Patient on anticoagulant therapy that cannot be temporarily withheld for performing catheterization\n* Patient has a single functioning kidney\n* Documented thrombocytopenia, clotting disorders or aortic aneurysms\n* Moribund patient, or patient with comorbidities limiting life expectancy to less than one year\n* Contraindication to recommended study medications or intravascular contrast material that cannot be adequately controlled with pre-medication\n* Concurrent enrollment in another trial\n* Main renal arteries \\< 4 mm in lumen diameter or \\< 20 mm in length\n* Aorto-renal angle that prevents a safe cannulation of the renal artery\n* Severe common femoral artery, common and/or external iliac artery, renal, iliac or aortic calcification or tortuosity that may compromise the safe performance and completion of the procedure\n* Hemodynamically or anatomically significant renal artery abnormality or stenosis in either renal artery\n* Any renal artery stenosis \\> 50% by visual assessment\n* Any renal artery aneurysm in either renal artery\n* A history of prior renal artery balloon angioplasty or stenting (for patients in Cohort A and B only, also a history of prior renal denervation at any time)'}, 'identificationModule': {'nctId': 'NCT01835535', 'briefTitle': 'Continued Safety and Performance of the TIVUS System', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cardiosonic'}, 'officialTitle': 'Clinical Evaluation of the Therapeutic Intra-Vascular Ultrasound (TIVUS™) System for Renal Denervation in Patients With Resistant Hypertension', 'orgStudyIdInfo': {'id': 'CLN02-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Severe Resistant HTN', 'description': 'Patients presenting with resistant hypertension and office systolic blood pressure of 160 mmHg (150 mmHg for DM) or greater', 'interventionNames': ['Device: TIVUS']}], 'interventions': [{'name': 'TIVUS', 'type': 'DEVICE', 'armGroupLabels': ['Severe Resistant HTN']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Perth', 'country': 'Australia', 'facility': 'Royal Perth Hospital', 'geoPoint': {'lat': -31.95224, 'lon': 115.8614}}], 'overallOfficials': [{'name': 'Michael Jonas, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kaplan Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cardiosonic', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}